Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests

NCT ID: NCT02505880

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-08-12

Brief Summary

In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).

Conditions

Minimally Invasive Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

1: General anesthesia

General anesthesia

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: DRUG

Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

2: Hypnosis

Hypnosis with local anesthesia

Group Type: EXPERIMENTAL

Local anesthetic + Hypnosis

Intervention Type: OTHER

Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg)

Interventions

Local anesthetic + Hypnosis

Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg)

Intervention Type: OTHER

General anesthesia

Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient hospitalized in infantile ambulatory surgery unit
• Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III
• Patient among whom the parents or the legal guardian gave their informed consent
• Patient member in a national insurance scheme

Exclusion Criteria

• Patient presenting a contraindication to general anesthesia
• Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chrystelle CS Sola, MD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

CHRU Montpellier

Montpellier, , France

Countries

France

References

Sola C, Devigne J, Bringuier S, Pico J, Coruble L, Capdevila X, Captier G, Dadure C. Hypnosis as an alternative to general anaesthesia for paediatric superficial surgery: a randomised controlled trial. Br J Anaesth. 2023 Mar;130(3):314-321. doi: 10.1016/j.bja.2022.11.023. Epub 2023 Jan 21.

Reference Type: DERIVED

PMID: 36690538 (View on PubMed)

Other Identifiers

2014-A01776-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

9518

Identifier Type: -

Identifier Source: org_study_id